Keratoconus
Conditions
Keywords
Lamellar transplant, Lyophilization, Corneas storage, Keratoconus patients, Best corrected visual acuity < 20/60, Signed the consent inform
Brief summary
\- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas
Detailed description
* After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of \< 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas. * Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy. * Results are going to be statistically analysed by SPSS program.
Interventions
PROCEDURELamellar transplant with lyophilized corneas
Sponsors
University of Sao Paulo
Sorocaba Eye Bank
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Keratoconus patient * BCVA \< 20/60 * No systemic diseases * Who signed the inform consent
Exclusion criteria
* BCVA \> 20/60 * Presence of deep opacities * Systemic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Topography | — |
| Orbscan | — |
| Pachmetry | — |
| Ultrasound Biomicroscopy | — |
| Confocal Microscopy | — |
| Masked Examiner to evaluate transparency and quality of the transplant | — |
Countries
Brazil
Outcome results
None listed